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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, detection, bacterial, for platelet transfusion products
510(k) Number BK170149
Tradename BacTx Bacterial Detection Kits
Device Name System, Detection, Bacterial, Detection Systems for Platelet Transfusion Products
Original Applicant
Immunetics, Inc.
27 drydock avenue
boston,  MA  02210 2377
Regulation Number866.2560
Classification Product Code
MZC  
Date Received01/16/2018
Decision Date 04/16/2018
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Immunology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product Yes
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